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Biomedical subjects

David L Steed

Publications and source records attributed to David L Steed.

6 recordsLinked to original sources

Clinical evaluation of recombinant human platelet-derived growth factor for the treatment of lower extremity ulcers.

BACKGROUND: Diabetic foot ulcer is a major health care problem that leads to amputation. METHODS: Patients with full-thickness diabetic neurotrophic foot ulcers present for longer than 8 weeks without healing were entered into one of five randomized, prospective, blinded clinical trials comparing treatment with platelet-derived growth factor (PDGF) or placebo gel for up to 20 weeks. The purpose of these trials was to assess the safety and efficacy of PDGF used with good wound care. Each patient had an adequate arterial blood supply, was free of infection, was off-loaded, and was extensively débrided. The ulcers had been present for at least 8 weeks. RESULTS: A total of 922 patients were entered into the study. Analysis of ulcers with a baseline area of less than 10 cm (95 percent of patients) showed that patients treated with PDGF at 100 mug/g had a significant increase in complete healing compared with patients given placebo (50 percent versus 36 percent, p < 0.007). PDGF also decreased the time to complete healing by 30 percent (14 weeks versus 20 weeks, p = 0.01). Adverse events were similar in both treatment groups, as were recurrent ulcer rates. CONCLUSION: PDGF applied once daily was effective in healing chronic diabetic neurotrophic foot ulcers when used in conjunction with good wound care.

Administration, Topical↗

Wound-healing trajectories as outcome measures of venous stasis ulcer treatment.

Outcome measures of venous ulcer healing are not uniformly accepted. Stringent criteria of 100% closure fail to provide information of healing over the entire span of repair. Wound-healing trajectories (plot of percentage of wound closure versus time of wound treatment) were constructed for 232 patients treated in eight clinical trials at two independent wound care/research centres. Trajectories were constructed for ulcers that totally healed (100% closure) and those that did not (<100% closure) over a 20-week period. Kaplan-Meier survival plots determined the percentage of patients achieving total healing versus time of treatment. The wound-healing trajectories were almost identical for patients achieving complete ulcer healing, as were the trajectories for patients with less than 100% closure. The trajectories for the ulcers healing completely were significantly different from those with <100% closure. Only 60% of all patients achieved 100% closure by 20 weeks. Using linear regression, it was predicted that it would take 31 weeks for all patients to achieve total healing. Total healing is an inadequate outcome measure for healing of venous stasis ulcers. Clinical trials using this measure would require excessive time periods. As wound-healing trajectories for patients treated at two centres mimic one another, shifting the wound-healing trajectory from one of impaired healing to one of a more ideal healing course may be considered a better outcome measure for determining healing of venous stasis ulcers.

Bandages↗

Debridement.

Debridement is defined as the removal of nonviable material, foreign bodies, and poorly healing tissue from a wound. Although surgeons recognize the importance of debridement, few data have been generated in randomized trials to support its use. Debridement provides for removal of tissue with the highest bacterial count, reliable cultures, and identification of osteomyelitis. The most direct form of debridement is surgical excision. For patients who are poor candidates for surgical debridement or have limited access to a surgeon, other forms of debridement (including mechanical, autolytic, enzymatic, and biologic) can be used. Although operative debridement is best performed by those with surgical training, the other forms of debridement can be accomplished by other allied health care professionals. Debridement remains an important adjunct to good wound care, but questions of what type, how much, and how often it should be performed remain unresolved.

Debridement↗

Wound-healing trajectories.

Healing of a wound is a dynamic process involving soluble mediators, a variety of cells, and extracellular matrix. These components are involved in a number of different processes or steps in healing, including coagulation, inflammation, fibroplasia, collagen deposition, epithelialization, and scar contraction with remodeling. The processes can be organized into three phases: inflammation, fibroplasia, and remodeling. The events in healing occur in an orderly and timely fashion, and there is significant overlap between each of the processes.

Acute Disease↗